Cellceutix Reports Kevetrin™ Dosing Increases and Prurisol™ Anti-Psoriasis Drug Stability Tests Underway
Beverly, MA — 06/17/13 — Cellceutix Corporation (OTCBB: CTIX) (the “Company”), a clinical stage biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, announces today that the pharmaceutical tablets for the Company’s clinical trial of Prurisol as a new drug candidate for the treatment of psoriasis have been formulated by Dr. Reddy’s Laboratories and are currently undergoing stability testing. The stability testing is scheduled to be completed in about 45 days.
“We have been advised that stability testing began approximately two weeks ago and that the Prurisol tablets will be shipped to the clinical site in Europe before the end of the 60-day stability research in preparation for the commencement of the clinical trial,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “We are enthusiastic about reaching another milestone for our company with the start of second clinical trial. We are very optimistic about the potential for Prurisol to reproduce the laboratory results showing the drug to effectively eliminate all signs of psoriasis.”
Cellceutix also wishes to inform shareholders that it has recently conducted discussions with the University of Bologna regarding Kevetrin, the Company’s novel anti-cancer drug currently in clinical trials at Dana-Farber Cancer Center and Beth Israel Deaconess Medical Center, for the planned clinical trial as a new drug candidate for Acute Myelogenous Leukemia, or AML. All regulatory submissions have been made and the hospital is awaiting Kevetrin reaching its Maximum Tolerated Dose in the trials at Dana-Farber before commencing their trial.
“We are taking a different approach to realize some of the benefits of conducting the clinical trials of both Prurisol and Kevetrin in Europe,” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “It is a similar strategy that companies like Clovis Oncology employ to follow European protocol to target a broader, yet more specific, patient population. Through a promising pipeline and efficient development model, Clovis has built an impressive valuation. In our current trials at Dana-Farber, the protocol requires that we only treat Stage IV cancer patients, which presents its own set of unique challenges that can slow research. The good news is we are likely more than half way there in terms of the trial, and we are still increasing dosage. We are very pleased with the results to date especially considering the lower doses to date. With reference to the planned University of Bologna trial, by utilizing protocol where a ‘measurable stage’ of the disease is not required for the patient, i.e., we are not limiting the trial to Stage IV patients, this should allow the trial to go much faster, and hopefully get that perfect “poster”.
As a completely new class of chemistry in medicine, Kevetrin™ has significant potential to be a major breakthrough in the treatment of solid tumors. Mechanism of action studies showed Kevetrin’s unique ability to affect both wild and mutant types of p53 (often referred to as the “Guardian Angel Gene” or the “Guardian Angel of the Human Genome”) and that Kevetrin strongly induced apoptosis (cell death), characterized by activation of Caspase 3 and cleavage of PARP. Activation of p53 also induced apoptosis by inducing the expression of p53 target gene PUMA. p53 is an important tumor suppressor that acts to restrict proliferation by inducing cell cycle checkpoints, apoptosis, or cellular senescence.
In more than 50 percent of all human carcinomas, p53 is limited in its anti-tumor activities by mutations in the protein itself. Currently, there are greater than 10 million people with tumors that contain inactivated p53, while a similar number have tumors in which the p53 pathway is partially abrogated by inactivation of other signaling components. This has left cancer researchers with the grand challenge of searching for therapies that could restore the protein’s protective function, which Kevetrin appears to be doing the majority of the time.
Further information on the clinical trial, titled “A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin (Thioureidobutyronitrile) Administered Intravenously, in Patients With Advanced Solid Tumors,” is available at: http://clinicaltrials.gov/ct2/show/NCT01664000?term=cellceutix&rank=1
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol “CTIX”. It is an emerging bio-pharmaceutical company focused on the development of its pipeline of compounds targeting areas of unmet medical need. Our flagship compound, Kevetrin™, is an anti-cancer drug which has demonstrated the ability in pre-clinical studies to regulate the p53 pathway and attack cancers which have proven resistant to today’s cancer therapies (drug-resistant cancers). Cellceutix also owns the rights to seven other drug compounds, including KM-133, which is in development for psoriasis, and KM-391 for the treatment of the core symptoms of autism. More information is available on the Cellceutix web site at www.cellceutix.com.
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